Kornimate/medical-research-clean huggingface dataset:
role of methylene blue in parotid surgery

Conditions: Parotid Tumor

Summary: usefulness of the methylene blue staining for identification of facial nerve in parotid gland surgery

the specific surgical morbidity remains significant in parotid gland surgery. in addition to temporary facial weakness and permanent facial nerve injury, postparotidectomy depression and frey's syndrome (gustatory sweating) are specific for this type of surgery. to reduce the surgical morbidity, several modifications of parotidectomy have been implemented but postsurgical complications remain especially facial nerve injury . to overcome this difficulty, an identification method might be used such as preoperative intravital staining of the gland with methylene blue (mb). although mb staining is not designed to be used as a sole technique, it can be combined with other techniques such as identification of the anatomic landmarks. mb staining is simple, inexpensive, and not time consuming technique.it is an indirect facial nerve identification technique, because there is no nerve handling,thus decreasing iatrogenic nerve impairment.after injection of the parotid gland with mb dye, fine white nerve fibers can be observed . tumors in the parotid gland are also easily seen because they are not stained and will be visible in the surgical field.

Eligibility criteria:
inclusion criteria: * all new cases presented with primary benign or malignant parotid tumors. exclusion criteria: * cases with secondary tumors of the gland
study of terlipressin versus placebo to treat hepatorenal syndrome type 1

Conditions: Hepatorenal Syndrome

Summary: the purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (hrs) type 1 when compared to placebo.


Eligibility criteria:
inclusion criteria: * chronic, or acute liver disease * rapidly progressive reduction in renal function, e.g. doubling of serum creatinine to \>2.5 mg/dl in less than two weeks. * no sustained improvement in renal function after diuretic withdrawal and plasma volume expansion * proteinuria \<500 mg per day * no evidence of granular casts in urinalysis or ultrasonographic evidence of obstructive uropathy or parenchymal renal disease exclusion criteria: * ongoing shock * uncontrolled bacterial infection * current significant fluid losses * current or recent treatment with nephrotoxic drugs (e.g. nsaids or aminoglycosides within 4 weeks) * acute liver disease due to factors known to be also directly nephrotoxic (e.g. acetaminophen overdose) * confirmed pregnancy * severe cardiovascular disease * evidence of intrinsic or parenchymal renal disease (e.g. acute tubular necrosis) * participation in other clinical studies within 30 days

Keywords: hepatorenal syndrome terlipressin
postoperative chemoradiation v.s radiotherapy for lymph node negative cervical cancer patients

Conditions: Cervical Cancer

Summary: this phase iii study is designed to examine if low-risk (lymph node negative), stage i a2-ii b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater toxicities but similar survival rate as those treated by radiotherapy alone.

cervical carcinoma is one of the most common gynecologic cancers worldwide. concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with high risk factors cervical cancer. however, the treatment modality in patients with low-risk (lymph node negative) is still disputable. it is not yet known whether cisplatin-based chemoradiotherapy are more effective than radiotherapy alone in treating these patients. therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemoradiotherapy vs. radiotherapy alone in lymph node negative patients with early-stage cervical cancer following radical hysterectomy.

Eligibility criteria:
inclusion criteria: * undertaken radical hysterectomy with diagnosis of invasive cervical cancer (non-small cell type) * negative lymph node * at least two risk factors (interstitial infiltration of greater than 1/3, vascular or lymphatic involvement, cervix neoplasms larger than 4 cm, nerve involvement) * eastern cooperative oncology group 0-2 * expected life span over 6 months. * no distant metastasis * adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl) * adequate renal functions(serum creatinine ≤ 1.5mg/dl) * adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value) * written informed consent exclusion criteria: * previous history of chemotherapy or radiation * hypersensitive reaction to platinum/paclitaxel agent * history of other cancer * concurrent systemic illness not appropriate for chemotherapy * active infection requiring antibiotics * pregnancy

Keywords: cervical cancer radiotherapy postoperative therapy chemotherapy
digital foot self-management program for older-diabetes

Conditions: Diabetes Mellitus; Type 2 Diabetes; Glucose Metabolism Disorders; Endocrine System Diseases; Metabolic Diseases

Summary: the aims of this proposed study are to evaluate the effect of a digital foot self-management program on the primary outcome of self-efficacy, and secondary outcomes of self-care behaviors, hba1c and health promotion satisfaction for older adults with type 2 diabetes.

literature reveals the needs for diabetic foot self-management intervention programs associated with positive changes in behavior. however, lack of studies focused on measure or improve health outcomes. promoting effective diabetic foot care strategies in community is more critical than ever during a pandemic such as covid. this study are to evaluate the effect of a digital foot self-management program on self-efficacy, self-care behaviors, hba1c and health promotion satisfaction for older adults with type 2 diabetes. the contents of the 4-week program include: using a digital platform to providing foot self-management (checking conditions of foot, cleaning, cutting or removing corns and calluses, trimming, clipping nails, foot exercise, dietary related to foot care, foot care logs, etc). a developed digital platform as a self-help foot self-management education resource. the program specifically developed for older adults with diabetes to assist and management their own feet at homes. week 1 face-to-face training session. week 2 to week 4 following phone call once per week and line messages 3 times per week.by research nurse to encourage and monitor participant's compliance with the program at home by using the digital platform. a total of 100 older adults with type 2 diabetes will be recruited from the 5 community clinics in southern taiwan.a computerised random number generated by an independent statistician will be used to allocate each potential participant to the control or intervention group in a one-to-one ratio. all participants will be blinded to group allocation. participants in control group will receive routine care provided in diabetes clinic, including routine check-ups and foot care education. while participants in the intervention group received the digital foot self-management program in addition to the routine care. data will be collected at baseline and 4 weeks from baseline for self-efficacy, self-care behaviors,health promotion satisfaction and 12 weeks from baseline for hba1c. the digital program will be delivered by trained registered nurse. a research assistant will be blinded to study protocol, who are employed to undertake data collection.

Eligibility criteria:
inclusion criteria: * have been diagnosed with type 2 diabetes. * ≧65 years. * possess and able to use a smart device (e.g. samsung galaxy, iphone, ipad, tabletop) * are able to speak and comprehend chinese exclusion criteria: * unable to perform physical activities. * cognitive impairments. * unable to read and speak chinese

Keywords: digital foot self-management foot care self-efficacy self-care behaviors
evaluation of effects of multiple dose regimens of chf 5074 on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment

Conditions: Alzheimer's Disease

Summary: to evaluate the effects of multiple dose regimens of chf 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.


Eligibility criteria:
inclusion criteria: * one or two ɛ4 alleles of the apolipoprotein e (apoe) gene. * diagnosis of amnestic mild cognitive impairment. * mini-mental state examination score higher than 24 at screening. exclusion criteria: * diagnosis of alzheimer's disease. * any medical condition that could explain the subject's cognitive deficits. * mri scans having evidence of pre-specified brain abnormalities. * history of stroke. * vitamin b12 or folate deficiency. * skin cancers and any cancer that is being actively treated. * diagnosis of schizophrenia or recurrent mood disorder. * abnormal kidney function. * concomitant use of any study prohibitive medication.
hyperion™ international registry trial

Conditions: Atrial Septal Defects; Patent Ductus Arteriosus

Summary: the purpose of this study is to determine the safety, performance and efficacy of the hyperion™ occluder systems during treatment of asd and pda patients.


Eligibility criteria:
inclusion criteria: * patient has asd or pda documented by a transoesophagial echocardiography (tee) or a transthoracic echocardiography (tte) and indication for closure that is amenable to treatment with the hyperion™ asd or pda occluder * for pda: patient age ≥ 1 year old * for asd: patient weighting ≥15 kg of any age * patient is willing and able to comply with specified follow-up evaluations * patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written notice of informed consent, approved by the appropriate ethics committee (ec) exclusion criteria: * pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test * patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year) * patient has a known hypersensitivity or contraindication to aspirin, heparin, and/or contrast sensitivity that cannot be adequately pre-medicated * currently participating in another clinical study * active endocarditis, active bacterial infection, or other infection producing bacteremia or sepsis * congenital or structural heart disease other than asd or pda * thrombus at the intended site of implant or documented venous thrombosis in venous access * severe pulmonary hypertension * vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction * asd or pda anatomy non suitable for the hyperion™ closure device * confinement to bed (increased risk for clot formation) * prior cardiac implantation of cardiac devices for asd or pda closure
hospital in-patient insulin study

Conditions: Diabetes Mellitus, Type 2

Summary: hyperglycaemia has been shown to increase morbidity and mortality in patients with critical illness, myocardial infarction and stroke. this study aims to look at patients with hyperglycaemia and reduce their blood sugar levels using differing combinations of subcutaneous and intravenous insulin.

this is a randomised trial involving patients with type ii diabetes who are brought into the hospital with a problem other than a diabetic emergency. patients will be included, who have a blood sugar \> than 17mmols. they will be randomised to one of two groups and either given intravenous or subcutaneous insulin. outcome measures are length of stay, glucose control and comparison of the two regimens. cost implications will also be analysed.

Eligibility criteria:
inclusion criteria: * type ii diabetes * blood glucose \> 17mmols exclusion criteria: * type i diabetes * hyperosmolar non-ketotic coma (honk) * diabetic ketoacidosis (dka) * myocardial infarction (mi) * vomiting

Keywords: diabetes mellitus
the effects of a botanical moisturizer and an unscented soap on eczema and itch

Conditions: Atopic Dermatitis (Eczema)

Summary: the purpose of this study is to examine the effects of a botanical moisturizer and an unscented soap on eczema severity, itch, mood, and various skin measures (such as skin hydration) in those with mild to moderate eczema.


Eligibility criteria:
inclusion criteria: * sex: female and male; * age : 18 years old and above; * phototype: i to iv; * type: caucasian; * subjects with active eczema condition the body (showing flakiness, irritation, itch and intense dryness); * subjects with a scorad of 25 - 50; * subjects with dry skin on the study areas; * subject barely wearing makeup; * subjects must not take antibiotics and / or apply any antifungal treatments (body/scalp) for 1 month before study start and during the entire study duration; * no change in hygiene, cosmetics, and make-up habits - except for the product(s) under study - during the entire study duration; * subjects agreeing not to change lifestyle habits during the study duration. * healthy subject; * subject having given her free informed, written consent; * subject willing to adhere to the protocol and study procedures; * subject with polish citizenship. exclusion criteria: * for women with childbearing potential: pregnant or nursing woman or woman planning to get pregnant during the study; * cutaneous pathology on the study zone (other than eczema); * use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the study product (the subjects are allowed to use their topical corticosteroids during the study if needed; the information about the treatment and the number of applications must be noted in the daily log); * subject having undergone a surgery under general anesthesia within the previous month; * excessive exposure to sunlight or uv-rays within the previous month; * subject enrolled in another clinical trial during the study period (concerns the studied zones).

Keywords: eczema skin care botanical dry skin itch
evaluation of immunogenicity and reactogenicity of various formulations of recombinant hepatitis b vaccine

Conditions: Hepatitis B

Summary: the purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis b vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * between 18 and 40 years old. * written informed consent will have been obtained from the subjects. * good physical condition as established by physical examination and history taking at the time of entry. * female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry. exclusion criteria: * pregnancy or lactation. * positivity for anti hepatitis antibodies. * any vaccination against hepatitis b in the past. * any previous administration of mpl. * elevated serum liver enzymes. * history of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * axillary temperature \> 37.5°c at the time of injection. * any acute disease at the moment of entry. * chronic alcohol consumption. * any treatment with immunosuppressive or immunostimulant therapy. * any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study. * history of allergic disease likely to be stimulated by any component of the vaccine. * administration of any other vaccine(s) or any immunoglobulin during the study period. * simultaneous participation in any other clinical trial

Keywords: hepatitis b engerix™-b recombinant hepatitis b vaccine adjuvant
nano-pulse stimulation (nps) in sebaceous hyperplasia

Conditions: Skin Lesion; Skin Abnormalities; Sebaceous Hyperplasia

Summary: this prospective, open label, muti-center study evaluates the use of nano-pulse stimulation (nps) in the treatment of sebaceous hyperplasia (sh) lesions less than 2.5mm in size.

the study is designed with each subject serving as his or her own control. a total of up to 75 subjects with 2-5 qualifying sh lesions will be enrolled and treated with either a 1.5-mm x 1.5-mm or 2.5-mm x 2.5-mm tip. all treated lesions will receive at least one nps treatment and evaluated at 30 days for lesion clearance. initial lesions scored as not clear or partially clear may undergo a second nps treatment. all subjects will have their lesions evaluated at 60 days post-primary or secondary treatment.

Eligibility criteria:
inclusion criteria: * males or females * presents with at least 2 and up to 5 clinically visible sh lesions * understands that 1 lesion will remain untreated to act as a reference * lesions must measure no greater than 2.5 x 2.5 at the outside margin * wishes to have at least 1 and perhaps 2 nps treatments to each study lesion * selection of the non-treated reference lesion will be randomly identified * willing to return for 4 or 5 total study visits at specified intervals over 60 or 90 days * agrees to photographic or other image capture methods of both the treated and untreated lesions. * agrees to avoid any other treatment to the nps treated and untreated sh lesions until the end of the nps study * has no evidence of active infection in the designated tissue prior to treatment and reports no infection within 90 days * is not allergic to lidocaine or lidocaine-like products exclusion criteria: * presence of implantable electronic devices that cannot be removed. e.g., pacemaker or automatic defibrillator * taking medications prescribed for cardiac arrhythmia at any time within 6 months prior to exposure to the nps device * sh lesions are located within the eye orbit or on the nose * active infection or history of infection in designated test area within 90 days prior to study initiation * use of oral steroid and/or retinoid use within the last 12 months * prior treatment to the identified sh lesions targeted for the study which occurred within 6 months prior to study start * is known to be immune-compromised and/or received immunosuppressant therapy within 6 months prior to study start * taking blood thinning medications * has insulin dependent diabetes * is known to be pregnant or lactating female

Keywords: nano-pulse stimulation nps
the safety and efficiency study of mesenchymal stem cell (19#isclife®-poi) in premature ovarian insufficiency

Conditions: Premature Ovarian Failure

Summary: evaluate the safety of human umbilical cord mesenchymal stem cells (hucmscs) in poi treatment; evaluate the effective hucmscs in poi treatment. compare different infusion mode, meanwhile compare with hormone replacement therapy (hrt) withdrawal, so that assessing the stem cell therapy.

premature ovarian insufficiency (poi) or premature ovarian failure (pof), is the loss of function of the ovaries before age 40, which has the features of menstrual disorder with high gonadotropic hormone and low estrogen. the morbidity of poi is about 0.1% among woman before 40 years, 10-28% among woman with primary amenorrhea, and 4-18% among woman with secondary amenorrhea. recent years research shows different sources of stem cell could be used to poi, and with effective results. above all, this experiment designed to as a single center, random, and control experiment. treat poi patients wit human umbilical cord mesenchymal stem cells (mscs). after regular follow-up and analysis, assessing the safety and effective of mscs in poi treatment.

Eligibility criteria:
inclusion criteria: * meet diagnostic criteria of european society of human reproduction and embryology * no hormonotherapy and chinese traditional medicine within 3 months; * understand and sign informed consent. exclusion criteria: * patient with congenital adrenocortical hyperplasia; * patient with cushing syndrome; * patient with thyroid dysfunction; * patient with hyperprolactinemia; * patient with pituitary amenorrhea or hypothalamic amenorrhea; * patient with hiv, hepatitis; * gene defect (eg. turner syndrome, fragile x syndrome) * serious drug allergy history; * suffering from thrombophlebitis, thromboembolism including venous thrombosis and arterial thrombosis; * history of treatment of ovarian cysts or ovarian surgery * with high tumor marker; * pregnant or lactating * receive other treatments that may affect the efficacy and safety of stem cells; * do not understand or without sign informed consent; * the attending physician believes that it is not suitable for participating in this trial

Keywords: premature ovarian failure premature ovarian insufficiency mesenchymal stem cell
next personalized cancer tx with multi-omics and preclinical model

Conditions: Metastatic Cancer

Summary: the next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. the genome analysis needs systematic infra and database based on personal genetic information therefore, a big data of genome-clinical information is important. to determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(pfs, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling and receive molecular profile directed treatments.

this study nickname is next-1 trial(next personalized cancer tx with multi). a single-center, open label trial to analysis of genetic information in advanced cancer. if the target is to be confirmed by molecular profile, the subgroup is going to umbrella trial type. defined below: next 1 trial is screening and feasibility -\> next trial is basket/umbrella study screening protocol(molecular screening prolongs survival)-\>next-1.1(gastric cancer),next-1.2(colorectal cancer),next-1.3(biliary tract cancer/pancreatic cancer),next-1.4(rare cancer),next-1.5(genitourinary cancer)

Eligibility criteria:
inclusion criteria: * pathologically confirmed metastatic malignancy * written informed consent exclusion criteria: * patients who do not agree with biopsy * patients who do not have enough tissue for acquisition